Study on Patritumab Deruxtecan and Pembrolizumab with Other Cancer Drugs for High-Risk Early-Stage Breast Cancer
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT06797635
This clinical trial is exploring a new combination of treatments for patients with high-risk early-stage breast cancer that is either triple-negative or hormone receptor-low positive and HER2 negative. The study aims to determine the safety and effectiveness of these treatments before surgery.
Patient Parameters
| Parameter | Options |
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Program Overview
Researchers are testing new treatments for certain types of early-stage breast cancer, specifically triple-negative and hormone receptor-low positive/HER2 negative breast cancer. The main goals are to see if the combination of patritumab deruxtecan, pembrolizumab, and chemotherapy is safe and well-tolerated, and if it reduces the number of cancer cells removed during surgery compared to just using pembrolizumab and chemotherapy.
Eligibility Criteria
Inclusion Criteria
- Have locally advanced breast cancer that has not spread to other parts of the body.
- Have a confirmed diagnosis of triple-negative or hormone receptor-low positive/HER2 negative breast cancer.
- If you have Hepatitis B, you must have been on antiviral therapy for at least 4 weeks and have an undetectable viral load.
- If you have a history of Hepatitis C, your viral load must be undetectable.
- Be in good general health with an ECOG performance status of 0 or 1.
- Have a heart function of 50% or higher as measured by specific heart tests.
Exclusion Criteria
- Have uncontrolled heart disease.
- Have significant eye disease affecting the cornea.
- Have HIV with a history of certain related diseases.
- Have previously received certain immune therapies or treatments for the current breast cancer diagnosis.
- Have metastatic breast cancer or certain advanced nodal involvement.
- Have another active cancer that has needed treatment in the past 5 years.
- Have active cancer spread to the brain or spinal fluid.
- Have a history of lung disease that required steroids or current lung issues.
- Have an active infection needing treatment.
- Have both active Hepatitis B and C infections.
- Have severe breathing problems due to lung illness.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Orchard Healthcare Research Inc. ( Site 0006) | 60077 | Skokie | Illinois |
| Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 0003) | 59102 | Billings | Montana |
| Northwest Cancer Specialists (Compass Oncology) ( Site 8003) | 97223 | Tigard | Oregon |
| SCRI Oncology Partners ( Site 7000) | 37203 | Nashville | Tennessee |
| Texas Oncology - DFW ( Site 8000) | 75246 | Dallas | Texas |
| Virginia Oncology Associates (VOA) ( Site 8001) | 23502 | Norfolk | Virginia |
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